Comparison of Epzicom and Truvada for the Initial Once Daily HIV Treatment

This study has been completed.

Sponsor:

International Medical Center of Japan

ClinicalTrials.gov Identifier:

NCT00544128

First Posted: October 16, 2007

Last Update Posted: March 30, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

A non-inferiority randomized control trial in treatment naïve HIV patients to compare virologic effect of two backbone regimens with Epzicom (lamivudine and abacavir) and Truvada (emtricitabine and tenofovir). Both arms are treated with fixed combination of ritonavir boosted atazanavir as key drugs.

In treatment naïve HIV-1-infected patients, once daily combination antiretroviral therapy containing ritonavir boosted atazanavir combined with Epzicom will offer non inferior antiretroviral efficacy compared to ritonavir boosted atazanavir combined with Truvada. This non inferiority hypothesis is studied by a randomized, open label, multicenter trial over 48 weeks as the primary endpoint and long term safety of both arms are followed for 144 weeks.

The primary endpoint is the antiretroviral effect over 48 weeks.

The secondary endpoints are;

The immunologic effects from baseline at the 48th and 144th week

Reasons of treatment failure by 144th week

Adverse events and their rate of incidence by 144th week

Serum concentration of tenofovir in selected patients

Serum concentration of atazanavir in selected patients

Renal complication in tenofovir arm

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

20 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Clinical diagnosis of HIV infection,

Antiretroviral initiation is recommended by current clinical guidelines,

Treatment naïve,

Age over 20 years old Japanese,

Able to obtain written informed consent

Exclusion Criteria:

Current malabsorption condition,

Prior use of lamivudine for hepatitis B treatment,

Positive serology of Hepatitis B surface antigen,

Patients who have following abnormal laboratory results within 6 weeks prior enrollment;

alanine aminotransferase is more than 2.5 times higher of upper normal limit

estimated glomerular filtration rate is less than 60ml/min by Cockcroft-Gault equation